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The purpose of this study was to evaluate efficacy and safety of etanercept 100 mg (50 mg twice a week) compared with 50 mg once a week in adult subjects with ankylosing spondylitis (AS) and previous failure to usual practice therapies in Spain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etanercept | Drug | Etanercept 50 mg twice a week (BIW) for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 20. | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement (vs. baseline) and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 40. | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain. |
Not provided
Inclusion criteria:
Exclusion criteria:
Contraindications for treatment with anti-TNF
Complete ankylosis of spine
Onset of treatment with DMARDs in the 4 weeks prior to baseline (SSZ, MTX and HCQ are permitted if the administrated dose has been maintained stable in the 4 weeks prior to baseline). Furthermore, patients with a dose of prednisone >10 mg/d or equivalent or modified in the 2 weeks prior to the baseline visit, those in whose infiltration has been performed with intraarticular corticosteroids has been performed in the 4 weeks prior to the screening visit and those who follow treatment with more than one NSAID in the 2 weeks prior to the baseline visit are excluded.
Previous treatment with other TNF inhibitors and other biological drugs
Abnormalities in hematology profiles defined by:
Important concomitant medical conditions, such as:-Class III or IV congestive heart failure according to New York Heart Association classification-Uncontrolled arterial hypertension (defined as screening systolic blood pressure > 160 mm Hg or screening diastolic blood pressure > 100 mm Hg)-Myocardial infarction within 12 months of the screening visit or unstable angina-Severe pulmonary disease requiring hospitalization or oxygen therapy-Diagnosis of multiple sclerosis or other central nervous system demyelinating disease -Presence or history of confirmed blood dyscrasias-Cancer or history of cancer (other than resected cutaneous basal cell or squamous cell carcinoma)-Serious infection (infection requiring hospitalization and/or intravenous antibiotics) within 1 month of administration of test article administration or active infection at screening or history of recurrent or chronic infection-Open cutaneous ulcers-Patients with known chronic infections as positivity to HIV, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) -Active tuberculosis infection (local guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF therapy must be followed)- Any condition that, in the investigator's judgment, might cause this study to be detrimental to the subject
Pregnant or breast-feeding women
Past or current psychiatric illness that would interfere with the subject's ability to comply with protocol requirements or give informed consent.
Treatment with any live (attenuated) vaccine within 4 weeks prior to baseline.
History of alcohol or drug abuse that would interfere with the subject's ability to comply with protocol requirements.
Treatment with any investigational drug within 3 months of screening visit.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21700683 | Derived | Navarro-Sarabia F, Fernandez-Sueiro JL, Torre-Alonso JC, Gratacos J, Queiro R, Gonzalez C, Loza E, Linares L, Zarco P, Juanola X, Roman-Ivorra J, Martin-Mola E, Sanmarti R, Mulero J, Diaz G, Armendariz Y, Collantes E. High-dose etanercept in ankylosing spondylitis: results of a 12-week randomized, double blind, controlled multicentre study (LOADET study). Rheumatology (Oxford). 2011 Oct;50(10):1828-37. doi: 10.1093/rheumatology/ker083. Epub 2011 Jun 23. |
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Patients were screened up to 6 weeks.
Patients were recruited in Spain from December 2006 to February 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept BIW | etanercept 50 mg twice a week (BIW) for 12 weeks |
| FG001 | Etanercept QW | etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept BIW | etanercept 50 mg twice a week (BIW) for 12 weeks |
| BG001 | Etanercept QW | etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 20. | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement (vs. baseline) and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain. | The analysis population was the intent to treat population. | Posted | Jun 2009 | Number | patients | 12 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etanercept BIW | etanercept 50 mg twice a week (BIW) for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrheic syndrome | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| U. S. Contact Center | Wyeth | clintrialresults@wyeth.com |
Not provided
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| etanercept/placebo |
| Drug |
Etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks |
|
| 12 weeks |
| Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 50. | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain. | 12 weeks |
| Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 70. | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain. | 12 weeks |
| Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6. | ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (patient global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0=no disease activity, 100=high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains and no worsening in the remaining domain. | 12 weeks |
| Number of Patients Achieving Partial Remission. | Partial remission defined as a score of less than 20 units (on a scale of 0-100, where 0=no disease activity, 100=high disease activity) in each of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains: patient global assessment of disease activity, pain, function, and inflammation. For scale, 100=high disease activity. | 12 weeks |
| Change in Nocturnal Back and Overall Spinal Pain From Baseline to Week 12. | Nocturnal back and overall spinal pain assessed by patients using a Visual Analog Scale (VAS) of 0 - 10 (0 = no pain and 10 = most severe pain). | Baseline and 12 weeks |
| Change in Physician and Patient Global Assessment (PGA) of Pain From Baseline to Week 12. | Patient pain assessed by physician and patient using a Visual Analog Scale (VAS) of 0 - 10 (0 = none and 10 = severe). | Baseline and 12 weeks |
| Change in Bath Ankylosing Spondylitis Functional Index (BASFI) From Baseline to Week 12. | BASFI is a validated self assessment tool that determines the degree of functional limitation in AS patients. Utilizing a VAS of 0-10 (0=easy, 10=impossible), patients answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions. | Baseline and 12 weeks |
| Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) From Baseline to Week 12. | BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) patient's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI final mean score was calculated taking all 6 VAS assessments. | Baseline and 12 weeks |
| Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) From Baseline to Week 12. | BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. | Baseline and 12 weeks |
| Change in Erythrocyte Sedimentation Rate (ESR) From Baseline to Week 12. | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube and is measured in mm/hour. Normal range is 0-30mm/h. A higher rate is consistent with inflammation. | Baseline and 12 weeks |
| Ankylosing Spondylitis Quality of Life (EuroQoL) Questionnaire | EuroQol questionnaire is intended to measure the quality of life by means of questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Answers to every question were grouped in two main categories: with problems (having some problems or absolutely unable) or without problems. | 12 weeks |
| Change in 36-Item Short-Form Health Survey (SF-36) From Baseline to Week 12. | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). | Baseline and 12 weeks |
| Improvement of Ocular Inflammatory Disease in Patients With Baseline Symptoms | 12 weeks |
| Change in C-reactive Protein (CRP) From Baseline to Week 12. | CRP is a marker of inflammation and measured in mg/l. A higher level is consistent with inflammation. | Baseline and 12 weeks |
| Withdrawal by Subject |
|
| Sponsor decision |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
|
|
|
| Secondary | Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 40. | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain. | The analysis population was the intent to treat population. | Posted | Jun 2009 | Number | patients | 12 weeks |
|
|
|
|
| Secondary | Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 50. | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain. | The analysis population was the intent to treat population. | Posted | Jun 2009 | Number | patients | 12 weeks |
|
|
|
|
| Secondary | Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 70. | ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain. | The analysis population was the intent to treat population. | Posted | Jun 2009 | Number | patients | 12 weeks |
|
|
|
|
| Secondary | Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6. | ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (patient global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0=no disease activity, 100=high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains and no worsening in the remaining domain. | The analysis population was the intent to treat population. | Posted | Jun 2009 | Number | patients | 12 weeks |
|
|
|
|
| Secondary | Number of Patients Achieving Partial Remission. | Partial remission defined as a score of less than 20 units (on a scale of 0-100, where 0=no disease activity, 100=high disease activity) in each of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains: patient global assessment of disease activity, pain, function, and inflammation. For scale, 100=high disease activity. | The analysis population was the intent to treat population. | Posted | Jun 2009 | Number | patients | 12 weeks |
|
|
|
|
| Secondary | Change in Nocturnal Back and Overall Spinal Pain From Baseline to Week 12. | Nocturnal back and overall spinal pain assessed by patients using a Visual Analog Scale (VAS) of 0 - 10 (0 = no pain and 10 = most severe pain). | The analysis population was the intent to treat population. | Posted | Jun 2009 | Mean | Standard Deviation | units on scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change in Physician and Patient Global Assessment (PGA) of Pain From Baseline to Week 12. | Patient pain assessed by physician and patient using a Visual Analog Scale (VAS) of 0 - 10 (0 = none and 10 = severe). | The analysis population was the intent to treat population. | Posted | Jun 2009 | Mean | Standard Deviation | units on scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change in Bath Ankylosing Spondylitis Functional Index (BASFI) From Baseline to Week 12. | BASFI is a validated self assessment tool that determines the degree of functional limitation in AS patients. Utilizing a VAS of 0-10 (0=easy, 10=impossible), patients answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions. | The analysis population was the intent to treat population. | Posted | Jun 2009 | Mean | Standard Deviation | units on scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) From Baseline to Week 12. | BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) patient's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI final mean score was calculated taking all 6 VAS assessments. | The analysis population was the intent to treat population. | Posted | Jun 2009 | Mean | Standard Deviation | units on scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) From Baseline to Week 12. | BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. | The analysis population was the intent to treat population. | Posted | Jun 2009 | Mean | Standard Deviation | units on scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change in Erythrocyte Sedimentation Rate (ESR) From Baseline to Week 12. | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube and is measured in mm/hour. Normal range is 0-30mm/h. A higher rate is consistent with inflammation. | The analysis population was the intent to treat population. | Posted | Jun 2009 | Mean | Standard Deviation | mm/hour | Baseline and 12 weeks |
|
|
|
|
| Secondary | Ankylosing Spondylitis Quality of Life (EuroQoL) Questionnaire | EuroQol questionnaire is intended to measure the quality of life by means of questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Answers to every question were grouped in two main categories: with problems (having some problems or absolutely unable) or without problems. | The analysis population was the intent to treat population. | Posted | Jun 2009 | Number | patients | 12 weeks |
|
|
|
|
| Secondary | Change in 36-Item Short-Form Health Survey (SF-36) From Baseline to Week 12. | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). | The analysis population was the intent to treat population. Two scored areas had a different "Number of Participants Analyzed" in the etanercept arm. Bodily pain had 45 and Emotional role limitations had 46. | Posted | Jun 2009 | Mean | Standard Deviation | units on scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | Improvement of Ocular Inflammatory Disease in Patients With Baseline Symptoms | The population for this assessment was patients who had ocular inflammatory disease at baseline. The number of patients analyzed is zero because no patients had symptoms of ocular inflammatory disease at baseline. | Posted | Jun 2009 | Number | patients | 12 weeks |
|
|
| Secondary | Change in C-reactive Protein (CRP) From Baseline to Week 12. | CRP is a marker of inflammation and measured in mg/l. A higher level is consistent with inflammation. | The analysis population is the intent to treat. | Posted | Jun 2009 | Mean | Standard Deviation | mg/l | Baseline and 12 weeks |
|
|
|
|
| 1 |
| 22 |
| EG001 | Etanercept QW | etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks | 2 | 26 |
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Viral respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Transaminases increased | Investigations | Non-systematic Assessment |
|
| Procedural dizziness | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| 0.5364 |
| No |
| Superiority or Other |
| 0.4969 |
| No |
| Superiority or Other |
| Self-care Without Problems |
|
| Self-care With Problems |
|
| Usual activities Without Problems |
|
| Usual activities With Problems |
|
| Pain/Discomfort Without Problems |
|
| Pain/Discomfort With Problems |
|
| Anxiety/Depression Without Problems |
|
| Anxiety/Depression With Problems |
|
| 0.8009 |
| No |
| Superiority or Other |
| Analysis provided for Usual activities. | Chi-squared | 0.4290 | No | Superiority or Other |
| Analysis provided for Pain/Discomfort. | Chi-squared | 0.0461 | No | Superiority or Other |
| Analysis provided for Anxiety/Depression. | Chi-squared | 0.5620 | No | Superiority or Other |
| Bodily pain |
|
| General health |
|
| Vitality |
|
| Social functioning |
|
| Emotional role limitations |
|
| Mental health |
|
| 0.9045 |
| No |
| Superiority or Other |
| Analysis provided for Bodily pain. | Wilcoxon (Mann-Whitney) | 0.8558 | No | Superiority or Other |
| Analysis provided for General health. | Wilcoxon (Mann-Whitney) | 0.3123 | No | Superiority or Other |
| Analysis provided for Vitality. | Wilcoxon (Mann-Whitney) | 0.3327 | No | Superiority or Other |
| Analysis provided for Social functioning. | Wilcoxon (Mann-Whitney) | 0.8334 | No | Superiority or Other |
| Analysis provided for Emotional role limitations. | Wilcoxon (Mann-Whitney) | 0.7998 | No | Superiority or Other |
| Analysis provided for Mental health. | Wilcoxon (Mann-Whitney) | 0.7125 | No | Superiority or Other |